A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants W… (NCT05361174) | Clinical Trial Compass
RecruitingPhase 1/2
A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer
United States53 participantsStarted 2022-07-20
Plain-language summary
This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC.
. Participants who have received the following previous therapy:
. Cohort 1 (Melanoma): Participants who have progressed within 12 weeks of last dose of anti-PD-1/PD-L1 blocking antibody and received BRAF/MEK inhibitor in those with BRAF mutations.
. Cohort 2 (NSCLC): Participants who should have received no more than 3 prior lines of therapy and:
. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Participants who is assessed as having at least one resectable lesion.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase I: Safety of IOV-4001
Timeframe: Up to 1 Year or depending on when the recommended phase 2 dose is determined
. Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation.
. Participants who have adequate organ function.
Exclusion criteria
. Participants who have melanoma of uveal/ocular origin.
. Participants who have symptomatic untreated brain metastases.
. Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.
. Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose.
. Participants who have any form of primary immunodeficiency.
. Participants who have another primary malignancy within the previous 3 years.
. Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD.